Medtronic MiniMed 9102 My Sentry Outpost User Manual MP6025332 011 1
Medtronic MiniMed, Inc. My Sentry Outpost MP6025332 011 1
Users Manual
MySentry TM User Guide © 2008, Medtronic MiniMed. All rights reserved. U.S., International, and foreign patent applications are pending. Paradigm® is a registered trademark of Medtronic MiniMed. MySentry™ is a trademark of Medtronic MiniMed. 6025332-011 061108 REF MMT-9100 MySentry Monitor Contents Chapter 1: Introduction ............................................................................. 1 Assistance .............................................................................................................2 How to use this guide ...............................................................................................2 User safety ............................................................................................................4 Indications .......................................................................................................4 Contraindications ...............................................................................................4 Warnings .........................................................................................................4 Power supply ..............................................................................................4 Required distance .........................................................................................5 Additional safety instructions ...........................................................................5 Precautions ......................................................................................................6 Monitor .....................................................................................................6 Notice .................................................................................................................6 RF communication .............................................................................................6 Chapter 2: Basics ..................................................................................... 9 The MySentry system ................................................................................................9 The Monitor .....................................................................................................9 The Outpost ................................................................................................... 10 The power supply ............................................................................................ 10 Monitor screens .................................................................................................... 11 Glucose screens ............................................................................................... 11 Alarm screens ................................................................................................. 11 Utilities screens .............................................................................................. 11 Quick status view ............................................................................................. 12 MySentry buttons .................................................................................................. 13 MySentry Monitor Chapter 3: Getting started ......................................................................... 15 Setting up communication ........................................................................................ 15 Linking the Monitor to the pump ........................................................................... 15 Linking the Monitor to the Outpost ........................................................................ 16 Checking the communication status ....................................................................... 17 Home configuration ................................................................................................ 18 Monitor with Outpost ................................................................................... 18 Monitor without Outpost ............................................................................... 18 Adjusting Monitor settings ........................................................................................ 19 Adjusting user information .................................................................................. 19 Adjusting the nightlight brightness ........................................................................ 20 Adjusting the display light .................................................................................. 20 Adjusting the alarm volume ................................................................................. 21 Chapter 4: Everyday use ........................................................................... 23 Monitoring glucose levels ......................................................................................... 23 Viewing a glucose snapshot ...................................................................................... 23 Viewing the glucose graph ........................................................................................ 24 6-hour view ............................................................................................... 25 3-hour view ............................................................................................... 26 12-hour view ............................................................................................. 26 24-hour view ............................................................................................. 27 Viewing the Privacy screen ....................................................................................... 27 Alarms ............................................................................................................... 28 Alarm settings ................................................................................................. 28 Responding to an alarm ...................................................................................... 29 Alarm history .................................................................................................. 29 Daily alarm reset ............................................................................................. 30 Morning ......................................................................................................... 30 Evening ......................................................................................................... 30 ii MySentry Monitor Chapter 5: Maintenance ............................................................................31 Cleaning the Monitor .............................................................................................. 31 Chapter 6: Specifications ...........................................................................33 MySentry Monitor specifications ................................................................................. 33 Monitor size ................................................................................................... 33 Monitor weight ................................................................................................ 33 Alarm types ................................................................................................... 33 Alarm messages and codes .................................................................................. 33 Alarm/alert history .......................................................................................... 34 Display ......................................................................................................... 34 Default settings ............................................................................................... 34 Alarm table .................................................................................................... 34 Power .......................................................................................................... 34 Operating Conditions ........................................................................................ 34 Storage conditions ........................................................................................... 35 MySentry Outpost specifications ................................................................................ 35 Outpost size ................................................................................................... 35 Outpost weight ............................................................................................... 35 Power .......................................................................................................... 35 Operating conditions ......................................................................................... 35 Storage conditions ........................................................................................... 36 MySentry power supply specifications .......................................................................... 36 Power supply .................................................................................................. 36 Recycling ............................................................................................................ 36 Icon table ........................................................................................................... 37 Guidance and manufacturers declaration ..................................................................... 37 Warranty ............................................................................................................ 43 Chapter 7: Frequently asked questions ..........................................................45 iii MySentry Monitor Chapter 8: End user software license agreement .............................................. 49 iv MySentry Monitor Introduction Thank for choosing Medtronic Diabetes (legally known as Medtronic MiniMed, Inc.) as your partner in diabetes management. We believe that the combination of state-of-the-art technology and the simple, menu-driven programming of the MySentry™ system will provide many benefits for you. Your MySentry system is designed to provide a simple and reliable way to remotely monitor a sensorenabled insulin pump that is worn by a person in your care. This device is ideally suited for nighttime use, when you worry most about glucose variations. This user guide is designed to help you understand the operation of your MySentry system. Please read this guide in its entirety before you begin using the system. Introduction MySentry Monitor Assistance Medtronic Diabetes provides a 24-hour HelpLine for assistance. The HelpLine is staffed with representatives who are trained in the setup and operation of the MySentry system, and who are able to answer any system-related questions. When calling the HelpLine or your local Medtronic Diabetes office, please have the MySentry device and its serial number available. The phone number for the 24 Hour HelpLine, as well as your MySentry serial number, is also listed on the back of the MySentry Monitor. Department Telephone number 24 Hour HelpLine (within the United States) 800.646.4633 24 Hour HelpLine (outside the United States) 818.576.5555 Web site www.medtronicdiabetes.com How to use this guide The terms and symbols used in this guide are in the following table. Convention Description Press Push and release the button. Select Press or to select an item, then press to perform the action (such as choosing a menu item or displaying a particular screen.) Monitor buttons Indicated by images; for example, press Introduction to return to the Utilities menu. MySentry Monitor Convention Menu paths Description Displayed in bold text; for example: Main Menu > Go to Utilities menu > Link to Pump The previous instruction directs you to do the following: 1 From the monitor, go to Main menu, then select Go to Utilities menu. 2 In the Utilities menu, choose Link to Pump. NOTE Provides additional information. CAUTION Warns of a potential hazard which, if not avoided, could result in death or serious injury. It may also describe potential serious adverse reactions and safety hazards. WARNING Notifies you of a potential hazard which, if not avoided, could result in death or serious injury. It may also describe potential serious adverse reactions and safety hazards. Go to the...screen. When a step instructs you to go to a screen, the path to that screen is included in the step. For example: Go to the LINK TO PUMP screen. Main menu > Go to Utilities menu > Link to Pump MySentry Monitor Referred to within procedures as Monitor. MySentry Outpost Referred to within procedures as Outpost. NOTE: This user guide shows sample screens only. Your monitor screens may look slightly different. Introduction MySentry Monitor User safety This section describes all user safety information that you need to know regarding the use of your MySentry system. Indications The MySentry system is indicated for the remote monitoring, within your home, of a single Medtronic MiniMed Paradigm 523/723 sensor-enabled insulin pump. The real-time glucose values provided by the Monitor, as received from the Paradigm 523/723 insulin pump, are not intended to be used directly for making therapy adjustments. Rather, they provide an indication that may require a confirmation fingerstick measurement. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not based on the value displayed by the Monitor or Paradigm 523/723 insulin pump. Contraindications None known. Warnings MySentry is intended to act as a personal sentry for your loved ones, but it is not a substitute for personal visual monitoring. Although MySentry has been designed and tested to meet or exceed the latest industry standards as required by EN, FDA and Underwriters Laboratories, MySentry can be susceptible to RF or electrical interference. Transmission of all data or alarms cannot be guaranteed with MySentry. This product does not provide any medical advice and should not be relied upon for such purpose. Power supply • MySentry notifies you if its power source (household current) fails. If this occurs, check pump data directly from the insulin pump. • Using an unqualified power supply may affect the operation of MySentry. Use only the Medtronic MiniMed power supply, part number MMT-9103. Introduction MySentry Monitor Required distance MySentry only displays real-time glucose values and alarms/alerts that are transmitted by a Paradigm 523/723 insulin pump. The required distance between the pump and the Outpost is six feet (1.8 meters) or less. The distance between the Outpost and the Monitor can be up to 100 feet (30.5 meters). If a pump is not within the required distance from the MySentry Monitor or MySentry Outpost, then real-time glucose values and any associated alarms or alerts from the Paradigm 523/723 insulin pump might not be received and displayed on the MySentry Monitor. Refer to your Paradigm 523/723 insulin pump for real-time glucose values and alarms or alerts. Additional safety instructions • Please refer to the Paradigm 523/723 user guide for pump warnings. • Read, follow, and keep all instructions identified within this guide. • Heed all warnings identified on the product, and within this guide. • Protect the power cord from being walked on or pinched, particularly at plugs, convenience receptacles, and the point where it exits from the device. • To reduce the risk of fire or electric shock, MySentry should not be exposed to water or moisture of any kind, including, but not limited to, dripping or splashing. Do place the Monitor or Outpost near objects filled with water, such as vases, sinks or bathtubs. • Do not block any ventilation openings. • Install MySentry in accordance with the manufacturer’s instructions. • Refer all servicing to qualified service personnel. Servicing is required when MySentry operates abnormally or has been damaged in any way, to include: dropping, crushing, exposure to rain, water or other liquids, or power supply cord or plug damage. If the MySentry is damaged in any way, refer to the Paradigm 523/723 pump for all operational and glycemic information. Introduction MySentry Monitor Precautions Review the following precautions before operating your device. Monitor • The Monitor does not control or affect the Paradigm 523/723 insulin pump in any way. It only displays operational and glycemic data received from the pump. • The Monitor displays only the most essential alarms received from the Paradigm 523/723 insulin pump. • The Monitor also displays certain alarms only one time. Notice CAUTION: Any changes or modifications to the devices not expressly approved by Medtronic Diabetes could interfere with your ability to operate the equipment and void your warranty. RF communication These devices comply with the United States Federal Communications Commission and international standards for electromagnetic compatibility. These devices comply with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) These devices may not cause harmful interference, and (2) these devices must accept any interference received, including interference that may cause undesirable operation. It does not interfere with any RF signals transmitted from outside sources. These standards are designed to provide reasonable protection against excessive radio frequency interference, and prevent undesirable operation of the devices from unwanted electromagnetic interference. Operation is subject to the following two conditions: These devices have been tested and found to comply with the regulations governing such devices in your area. For the specific regulation and test results for your area, please contact your local representative. Introduction MySentry Monitor These devices generate, use, and can radiate radio frequency energy and, if installed and used in accordance with the instructions, may cause harmful interference to radio communications. If the devices do cause interference to radio or television reception, you are encouraged to try to correct the interference by one or more of the following measures: • • • Reorient or relocate the MySentry components. • Decrease the distance between the MySentry Monitor and Paradigm Revel insulin pump to six feet or less. • Increase the separation between MySentry devices and the device that is receiving/emitting interference. Decrease the distance between the MySentry Monitor and MySentry Outpost to 100 feet or less. Decrease the distance between the MySentry Outpost and Paradigm Revel insulin pump to six feet or less. If other devices that employ radio frequencies are in use, such as cell phones, cordless phones and wireless networks, they may prevent communication between the MySentry system and the Paradigm Revel insulin pump. This interference does not cause any incorrect data to be sent and does not cause any harm to your devices. Moving away from, or turning off, these other devices may enable communication. If you continue to experience RF interference, please contact your local Medtronic MiniMed representative, or call the 24 Hour HelpLine (see the Assistance section in this chapter). RF power The MySentry and Outpost system operate at a frequency of 2.4 GHz and a power of 100 milliwatts. It must be used at distances greater than 7.9 inches (20 cm) from the human body, except for hands and wrists. WARNING:The MySentry Monitor and Outpost have been approved for use where the Monitor and Outpost are used at distances greater than 20 cm from the human body (with the exception of hands and feet). Operation at distances of less than 20 cm is strictly prohibited. Introduction MySentry Monitor Introduction MySentry Monitor Basics The MySentry system MySentry is an integrated system consisting of a monitor, a radio-frequency-operated repeater, and a power supply. The Monitor provides remote viewing of Paradigm 523/723insulin infusion pump status, glucose data, trends and alarms. The Outpost repeater relays the insulin pump data to the Monitor. The power supply connects the Monitor to a standard electrical wall socket. The Monitor The Monitor (MMT-9100) receives data directly from the Paradigm 523/723 sensor-enabled pump (if within range), or remotely through the Outpost. The Monitor powers on when you plug the power supply into both the Monitor and a wall socket. It does not use batteries, and has no On or Off button. After the Monitor is properly linked to an insulin pump, it does not display data from other MySentry systems or insulin pumps, even if they are in the vicinity. The Monitor can, with minimum user interaction, receive data transmitted by the insulin pump, including glucose sensor values, historical graphs, pump status, alarms, remaining insulin in the reservoir, and the amount of time remaining until a glucose sensor calibration is required. Basics MySentry Monitor CAUTION: Never use sharp objects to press the buttons on your MySentry device as this can damage the buttons or compromise the seal of the device. Some examples of sharp objects that may damage the keypad are fingernail files, pens or pencils, paper clips, knives, scissors, and keys. The Outpost The Outpost (MMT-9102) receives data produced by the Paradigm 523/723 sensor-enabled insulin pump and transmits this data to the Monitor. It plugs into a regular wall socket and communicates with the pump and Monitor while maintaining data integrity. The required distance between the Outpost and the pump is six feet (1.8 meters) or less. The distance between the Outpost and the Monitor can be up to 100 feet (30.5 meters). The power supply The 5V DC power supply (MMT-9103) plugs into the back of the Monitor and a regular wall socket and provides electrical power to the Monitor. 10 Basics MySentry Monitor Monitor screens This section describes the general types of Monitor screens. It does not include all screens. Glucose screens Access the Glucose screens by pressing use chapter for more information. . See the Monitoring glucose levels section in the Everyday Alarm screens The Alarm screens are displayed when the Monitor receives an alarm or glucose alert from the pump, or when the Monitor has a communication problem. See the Alarms section in the Everyday use chapter for more information. Utilities screens The Utilities menu screens allow you to set up communication with the pump and Outpost, enter user information, and adjust preferences such as alarm volume. See the Setting up communication and Adjusting Monitor settings sections in the Getting started chapter, for more information. Basics 11 MySentry Monitor Quick status view MySentry allows you to quickly view pump and sensor status. The following information icons are displayed along the top of each glucose-related screen, as well as the confidential screen. 1. User: Displays the initials and image of the monitored pump user. 2. Battery: Indicates how much power remains in the monitored pump battery. 3. Reservoir: Indicates how many insulin units remain in the monitored pump reservoir. 4. Time: Displays the time currently shown on the monitored pump. 5. Communication status: Shows the signal strength between the pump and Monitor. More bars means stronger signal. 6. Next sensor recalibration: Indicates how many hours remain before the monitored pump must be recalibrated. 7. Next sensor change: Indicates how much time remains before the sensor must be replaced on the monitored pump user. 12 Basics MySentry Monitor MySentry buttons The Monitor screen display important information such as alarm messages, insulin pump status, and glucose trends. The buttons on the Monitor face are used to navigate through the MySentry system options and screens. The Monitor buttons work by creating an electrical connection between your finger and an embedded sensor. Unlike regular buttons, they require a certain amount of surface contact between your finger and the button in order to work properly. The illustration to the right shows the correct and incorrect way to activate the Monitor buttons. Incorrect Correct The buttons are also lighted when they are active for a given screen; they are not lighted when they are not active for a given screen. The following table shows you the functions and properties of each button. Button Uses VIEW • • • Accesses the Main Menu Cycles through the Glucose screens Updates the display with another view of data BACK • • • Cancels the current operation Cycles backwards through the sensor graph Displays the previous screen in a sequence Basics 13 MySentry Monitor Button Uses • Switches the nightlight on and off • Silences alarms and disables the audio so that alarms display only on screen, such as when the pump that is being monitored has gone out of range. • • Selects the previous menu option Increases the glucose graph display range • • Selects the highlighted option Moves forward in time on the graph screen • • Selects the next menu option Decreases the glucose graph display range NIGHTLIGHT SILENCE UP NEXT DOWN 14 Basics MySentry Monitor Getting started Setting up communication Before you can use the MySentry system, you must set up communication from the pump to the Monitor, and the Monitor to the Outpost (if used). The following linking procedures only need to be performed once, unless the Monitor or Outpost is unplugged or an alarm has cleared the pump settings. If so, then you must re-link the Monitor to the pump. NOTE: It is recommended that you place the pump, Monitor, and Outpost in one location during the setup process, and you not move any component until they are linked. After the components are successfully linked, you can move them to their permanent locations. The Monitor and Outpost work best if they stay in one location in your home. Linking the Monitor to the pump Do not move the pump or Monitor during this process. Remove the pump from the user and place it within six feet (183 cm) of the Monitor. Use the power supply provided with the MySentry system to plug the Monitor into a standard electrical wall outlet. If the Monitor is not linked to a pump, the Link to Pump screen displays. If the Link to Pump screen does not display, follow these steps: a. Press until the main menu displays. b. Go to the Link to Pump screen. Main Menu > Go to Utilities Menu > Link to Pump Getting started 15 MySentry Monitor Follow the onscreen instructions on your Monitor to set up the pump. A rotating circle indicates that the linking step is in process, while the Monitor locates the pump. It takes up to approximately two minutes to complete the linking process. If the linking process fails, reposition the Monitor and pump and repeat steps 1 through 4. If the Monitor is still unable to link to the pump, call the 24 Hour Helpline (1-800-646-4633). Linking the Monitor to the Outpost Do not move the Monitor or Outpost during this process. Place the Outpost within six feet of the Monitor. Do not plug in the Outpost until directed to do so. From the Main Menu, go to the Link to Outpost screen. Main menu > Go to Utilities menu > Link to Outpost Follow the onscreen instructions. It takes approximately two minutes to complete the linking process, and during this time the Outpost flashes slowly. Once the linking process is complete, the Outpost stays lit. If the linking process fails, reposition the components and repeat steps 1 through 4. If the Monitor is unable to link to the Outpost, call the 24 Hour Helpline. The phone number for the 24 Hour HelpLine and the Outpost serial number are listed on the back of the Outpost. 16 Getting started MySentry Monitor Checking the communication status To verify that the Monitor is successfully communicating with the pump and the Outpost, go to the Network Status screen. Main Menu > View Network Status Communication status is shown for the link between the Monitor and the pump, and the link between the Monitor and the Outpost. Solid bars indicate successful communication. Empty, flashing bars indicate a communication problem. The more bars, the stronger the connection signal strength. If communication is lost, a Monitor alarm displays that indicates whether the issue is with the pump or the Outpost. Communication issues are typically resolved by moving the devices closer to one another. Getting started 17 MySentry Monitor Home configuration Once MySentry is linked to the pump, use the following examples as guidelines for positioning the system within your home. Monitor with Outpost Monitor without Outpost 18 Getting started MySentry Monitor Adjusting Monitor settings Follow the procedures in this section to adjust your monitor settings. You can change these settings at any time. NOTE: In the procedures below, use the and buttons to scroll through each list of options. Adjusting user information The Enter User Info screen enables you to adjust the initials of the person wearing the pump, and the pump user image. It also displays the pump serial number, which is obtained when the pump is linked to a Monitor. To adjust this information, perform the following procedure. From the Main Menu, go to the Enter User Info screen. Main Menu > Go to Utilities Menu > Edit User Info Scroll to locate each user initial, pressing to confirm your selection. After you select the second initial, the user image displays. Scroll to choose your desired image, then press confirmation screen displays. .A Getting started 19 MySentry Monitor Adjusting the nightlight brightness There is a nightlight on the back of the Monitor to help you find it in the dark. You can adjust the nightlight to your desired level of brightness. From the Main Menu, go to the Adjust Nightlight screen. Main Menu > Go to Utilities Menu > Adjust Nightlight Brightness Follow the instructions on screen to adjust the brightness to your desired level. NOTE: To switch off the nightlight, press Adjusting the display light The display light is used during waking hours. You can adjust the display light to your desired level of brightness. From the Main Menu, go to the Adjust Screen Brightness screen. Main Menu > Go to Utilities Menu > Adjust Screen Brightness Follow the onscreen instructions to adjust the brightness to your desired level. 20 Getting started MySentry Monitor Adjusting the alarm volume This setting allows you to adjust the alarm volume. From the Main Menu, go to the Adjust Alarm Volume screen. Main Menu > Go to Utilities Menu > Adjust Alarm Volume Follow the instructions on screen to adjust the volume to your desired level. NOTE: If the Alarm Silence option is on, then the alarm is silent. See the Alarm settings section in the Everyday use chapter for information about the Alarm Silence feature. Getting started 21 MySentry Monitor 22 Getting started MySentry Monitor Everyday use This chapter contains information about MySentry features that you are likely to use on a daily basis. This includes responding to alarms, checking current glucose levels, and viewing the glucose graphs. Monitoring glucose levels MySentry gives you the ability to quickly view the pump user’s most recent glucose reading at any time, or view a more detailed graph that shows glucose readings over a number of hours. If the glucose readings exceed the values defined in the pump, or if there is a problem with the sensor or transmitter, a glucose alarm displays. See the Responding to an alarm section in the Everyday use chapter for more information about alarms. Viewing a glucose snapshot The Glucose Snapshot screen displays the current glucose reading recorded in the pump, and the time at which the reading was made. Everyday use 23 MySentry Monitor To view the current glucose snapshot, press NOTE: If the glucose level is less than 40 mg/dL (2.2 mmol/L) or greater than 400 mg/dL (19.4 mmol/L), then the Monitor indicates that the glucose level is out of range. time of the glucose snapshot current unit of measure The snapshot shows all of the (mmol/L or mg/dL) pump’s current settings and current glucose measurements. The glucose trend reading indicates whether glucose levels are stable, rising, rising rapidly, dropping, or dropping rapidly, and correspond to the rapid change arrows on the pump. Viewing the glucose graph The glucose graph displays glucose data in a range of 3 hours, 6 hours, 12 hours, or 24 hours. To view the glucose graph, press from the Glucose Snapshot screen. Press and to navigate forward and backward in time across the graph. Press and to increase or decrease the amount of time represented on the graph. 24 Everyday use MySentry Monitor 6-hour view glucose scale target glucose range glucose readings time and glucose reading at cursor location Everyday use 25 MySentry Monitor 3-hour view 12-hour view 26 Everyday use MySentry Monitor 24-hour view Viewing the Privacy screen The Privacy screen allows you to see an overview of the system data without displaying any specific glucose details. To activate this screen, press from the glucose graphs screen. Everyday use 27 MySentry Monitor Alarms MySentry displays three types of alarms: • Monitor alarms display when there are communication issues encountered by the Monitor. They indicate whether the communication issue is with the pump or the Outpost, and include the time that communication was lost. If this type of alarm occurs, do the following: • Move the pump closer to the Outpost. • Move the Outpost closer to the Monitor. You can check the communication status by going to the View Network Status screen. Main Menu > View Network Status • • Pump alarms display when your pump generates an alarm or alert. The Monitor displays most alarms and alerts generated by the pump, such as Weak Battery or Empty Reservoir. An explanation of each pump alarm or alert can be found in the pump user guide. Glucose alarms display when a glucose reading causes a sensor alert on the pump (for example, Rise Rate), or when there is an issue with the sensor or the transmitter (for example, Change Sensor). An explanation of each glucose alarm can be found in the pump user guide. Alarm settings You can adjust the alarms as follows: • Setting the volume — Go to the Adjust Alarm Volume screen. Main Menu > Go to Utilities Menu > Adjust Alarm Volume For more information, see the Adjusting the alarm volume section in the Getting started chapter. 28 Everyday use MySentry Monitor • Alarm Silence feature — To switch the Alarm Silence feature on or off, make sure there are no alarms currently displayed on the monitor, then press indicates alarms are silent Responding to an alarm The Monitor displays alarms sent from the pump. However, clearing an alarm on the Monitor does not clear it on the pump. When an alarm is received, one of the following happens, depending on the alarm mode: • • Standard mode — the alarm tone sounds and the alarm text is displayed. The alarm text remains on the screen. Press once to silence the alarm, and twice to clear it. Silent Alarm mode — the alarm text is displayed. Press to clear the alarm. If the pump is out of range of either the Monitor or Outpost, the Monitor does not display alarms sent from the pump. See the Alarms section in the Everyday use chapter for examples and descriptions of the each type of alarm screen. Alarm history You can view up to the 12 most recent alarms the Monitor has received. From the Monitor, go to the Alarm History screen. Main menu > View Alarm History Press and to scroll through the available alarms. Everyday use 29 MySentry Monitor Daily alarm reset To account for planned periods of time when the pump is out of the range of the Monitor or Outpost, perform the following daily procedure. Morning Before the pump goes out of range, silence your Monitor. If the pump has already gone out of range and the Monitor alarms, clear the alarm. Silence the Monitor to avoid future lost connection alarms while the pump is out of range. Evening Press to clear the alarm. Press to un-silence the Monitor. 30 Everyday use MySentry Monitor Maintenance This section provides information on how to clean your Monitor. Make sure you have the following items before you begin cleaning your Monitor: • • • Clean cloths Clean water Mixture of clean water and mild liquid soap Cleaning the Monitor The following procedure describes how to clean your Monitor. Never place the Monitor directly in water. Never try to clean the inside of the Monitor. Use only a damp cloth and mild liquid soap to clean the Monitor. Never use organic solvents such as lighter fluid, nail polish remover, or paint thinner to clean the Monitor. • Never use lubricants of any kind to clean the Monitor. CAUTION: • • • • To clean the Monitor: Make sure the Monitor is unplugged from the power supply. Dampen a clean cloth with mild liquid soap and warm water, and wipe the outside of the Monitor. Dry the Monitor by wiping it with the dry part of the cloth. Maintenance 31 MySentry Monitor 32 Maintenance MySentry Monitor Specifications MySentry Monitor specifications Monitor size • • • Height: approximately 5.7 inches (14.4 cm) Width: approximately 7.0 inches (18.0 cm) Depth: (thickness) approximately 3.7 inches (9.4 cm) Monitor weight Approximately 1.5 lbs (680.4 grams) Alarm types • • Audible tone — The alarm tone increases from a beep to a siren when no action is taken for that alarm. Visual — The alarm name displays and the key flashes. Alarm messages and codes • • Alarm information appears on the monitor screen. Types of alarm information: • alarm source (Monitor, pump, glucose sensor) • alarm name • alarm message (what to do when you receive the alarm) Specifications 33 MySentry Monitor Alarm/alert history Maximum number of recent alarms or alerts recorded: 12 Display Type: LCD (Liquid Crystal Display) Default settings Feature Alarm Silence Options Default Setting Possible values – On – Off Limits, Range of Values Off – On – Off Alarm Type – Sound and visual – Visual only Sound and visual Possible values Beep values – Volume settings from 1 to 6 Visual only – Flashing indicator Alarm table Every pump alarm that stops insulin delivery is sent to MySentry to notify you of the condition. However, it is possible that the cause of the alarm may prevent further communication until the condition is fixed. Power Medtronic MiniMed AC power supply, part number MMT-9103. Operating Conditions • Temperature: +41° F (+5°C) to +104° F (+40°C). 34 Specifications MySentry Monitor • • Humidity: 5% to 85% relative humidity. Transportation: +41° F (+5°C) to +104° F (+40°C). Storage conditions • • • Temperature: +23° F (-5°C) and +113° F (+45°C). Humidity: Up to 95% relative humidity. Transportation: 5% to 85% relative humidity. MySentry Outpost specifications Outpost size • • • Height: approximately 4.0 inches (10.2 cm) Width: approximately 2.6 inches (6.60 cm) Depth: (thickness) approximately 2.0 inches (5.0 cm) Outpost weight Approximately 0.3 lbs (131.0 grams) Power • • • Standard AC power, 5VDC 3A Part Number MMT-9102 Protection against electric shock: Class II Operating conditions • • • Temperature: +41° F (+5°C) to +104° F (+40°C). Humidity: 5% to 85% relative humidity. Transportation: +41° F (+5°C) to +104° F (+40°C). Specifications 35 MySentry Monitor Storage conditions • • • Temperature: +23° F (-5°C) and +113° F (+45°C). Humidity: Up to 95% relative humidity. Transportation: 5% to 85% relative humidity. MySentry power supply specifications Power supply • • • Standard AC power supply: 5VDC Part Number MMT-9103 Protection against electric shock: Class II Recycling Recycle all parts and packaging materials per your local regulations. 36 Specifications MySentry Monitor Icon table Attention: See Instructions for Use Date of manufacture (year - month) Catalogue number REF Device serial number S/N Quantity per package (1) (1X) Radio communication Polarity of d.c. power connector Guidance and manufacturers declaration Guidance and Manufacturers Declaration – Electromagnetic Emissions The MySentry system is intended for use in the electromagnetic environment specified below. The customer or the user of the MySentry system should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment – Guidance RF emissions Test: CISPR 11 Group 2 MySentry system must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. Specifications 37 MySentry Monitor Guidance and Manufacturers Declaration – Electromagnetic Emissions The MySentry system is intended for use in the electromagnetic environment specified below. The customer or the user of the MySentry system should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment – Guidance RF emissions Class B CISPR 11 Harmonic emissions Class B IEC 61000-3-2 Voltage fluctuations/flicker emissions IEC 61000-3-3 38 Specifications TBD The MySentry system is suitable for use in all establishments, including domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. MySentry Monitor Guidance and Manufacturers Declaration – Electromagnetic Immunity The MySentry system is intended for use in the electromagnetic environment specified below. The customer or the user of the MySentry system should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment – Guidance Electrostatic discharge (ESD) ±6 kV contact ±30 kV air IEC 61000-4-2 ±8 kV air (<5% relative humidity) Electrical fast transient/burst ±2 kV for power supply lines ±2 kV for power supply lines TBD IEC 61000-4-4 ±1 kV for input/output lines ±1 kV for input/ output lines TBD Surge ±1 kV line(s) to line(s) ±1 kV line(s) to line(s) TBD ±2 kV line(s) to earth ±2 kV line(s) to earth TBD IEC 61000-4-5 TBD Specifications 39 MySentry Monitor Guidance and Manufacturers Declaration – Electromagnetic Immunity The MySentry system is intended for use in the electromagnetic environment specified below. The customer or the user of the MySentry system should assure that it is used in such an environment. Immunity Test Voltage dips, short interruptions and voltage variations on power supply lines IEC 61000-4-11 Power frequency (50/60 Hz) magnetic field IEC 60601 Test Level Compliance Level <5% UT (>95% dip in UT) for 0.5 cycle <5% UT (>95% dip in UT) for 0.5 cycle TBD 40% UT (60% dip in UT) for 5 cycles 40% UT (60% dip in UT) for 5 cycles TBD 70% UT (30% dip in UT) for 25 cycle 70% UT (30% dip in UT) for 25 cycle TBD <5% UT (>95% dip in UT) for 5 seconds <5% UT (>95% dip in UT) for 5 seconds TBD 3 A/m 3 A/m TBD IEC 61000-4-8 NOTE: UT is the a.c. mains voltage prior to application of the test level. 40 Electromagnetic Environment – Guidance Specifications MySentry Monitor Guidance and Manufacturers Declaration – Electromagnetic Immunity The MySentry system is intended for use in the electromagnetic environment specified below. The customer or user of the MySentry system should assure that it is used in such an electromagnetic environment. Immunity Test Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 IEC 60601 Level 10Vrms 150kHz to 80MHz 3V/m 80MHz to 2.5GHz Compliance Level 10Vrms 150kHz to 80MHz Electromagnetic Environment Guidance TBD 3V/m NOTE: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption, and reflection from structures, objects and people. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcasts and TV broadcast cannot be predicted theoretically with accuracy. To access the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the MySentry System is used exceeds the applicable RF compliance level above, the MySentry System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the MySentry System. Specifications 41 MySentry Monitor Recommended separation distances between portable and mobile RF communications equipment and the MySentry System The MySentry system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the MySentry users can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the MySentry system as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter (W) Separation distance according to the frequency of transmitter (m) 80MHz to 800MHz 800MHz to 2,5GHz d = 0.35 P d = 0.70 P 0.01 0.035 0.07 0.1 0.11 0.11 0.35 0.7 10 1.1 2.2 100 3.5 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 42 Specifications MySentry Monitor Warranty Medtronic Diabetes warrants the Medtronic MySentry Monitor and MySentry Outpost against defects in materials and workmanship for a period of three months from the date of purchase. During the warranty period, Medtronic Diabetes will, at its discretion, either repair or replace (with a new or recertified Monitor or Outpost, at Medtronic Diabetes’ discretion) any defective Monitor or Outpost, subject to the conditions and exclusions stated herein. In the event that the Monitor or Outpost is repaired or replaced, the warranty period will not be extended. This warranty is valid only if the MySentry Monitor or MySentry Outpost is used in accordance with the manufacturer’s instructions. This warranty will not apply: • • If damage results from changes or modifications made to the Monitor or Outpost by the user or third persons after the date of manufacture. If damage results from service or repairs performed by any person or entity other than the manufacturer. If damage results from a Force Majeure or other event beyond the control of the manufacturer. • If damage results from negligence or improper use, including but not limited to: improper storage, submersion in water or physical abuse, such as dropping or otherwise. This warranty shall be personal to the original user. Any sale, rental or other transfer or use of the product covered by this warranty to or by a user other than the original user shall cause this warranty to immediately terminate. This warranty does not apply to any accessories. The remedies provided for in this warranty are the exclusive remedies available for any breach hereof. Neither Medtronic Diabetes nor its suppliers or distributors shall be liable for any incidental, consequential, or special damage of any nature or kind caused by or arising out of a defect in the product. All other warranties, expressed or implied, are excluded, including the warranties of merchantability and fitness for a particular purpose. Specifications 43 MySentry Monitor 44 Specifications MySentry Monitor Frequently asked questions This chapter answers and provides further information for the most frequently asked questions about the MySentry system. How do I turn the monitor on/off? Turn the Monitor on/off by plugging it into, and out of, the power supply. There is no power switch. How many pumps does MySentry monitor? MySentry is designed to monitor a single pump. How often does the pump send a transmission? The pump sends a transmission every minute. What is the RF frequency that the MySentry transmitter uses? The MySentry operates at ultra high frequency, similar to a mobile phone. What situations will cause RF interference? Most cellular (mobile) phones and 900 MHz cordless phones, when transmitting or receiving, may cause significant interruption of transmitter-receiver communication. It is likely that other devices operating in similar frequency ranges will have a similar effect. This interference, however, does not cause any incorrect data to be sent and will not cause any harm to your transmitter. The pump includes a programmable WEAK SIGNAL alert that notifies you when one or more expected transmissions were not received as expected by the pump. (The pump will also issue a LOST SENSOR alert if communication is interrupted for an extended period of time.) Frequently asked questions 45 MySentry Monitor How do I resolve RF interference issues? When you experience an RF communication issue, the MySentry Monitor identifies which device is having the problem by issuing an alarm. Communication problems can usually be resolved by: • • • ensuring that there is less than six feet (1.8 meters) between the pump and Monitor, or the pump and Outpost; turning off or moving away from other RF transmitting devices; reorienting or relocating the transmitter or receiving device, or both. Communication problems may also occur due to cellular telephone interference. Testing conducted with several different cellular telephones indicates that, while a glucose value is being transmitted, using a cell phone within 12 inches (31 cm) of receiving devices, transmitters, or RF glucose meters can interfere with the reception of transmitted values. In the event of such interference, normal communication can be re-established by: • • turning the cell phone off; keeping the cell phone at least 12 inches (31 cm) away from the receiving device, transmitter or glucose meter when a glucose measurement is being transmitted. What is the recommended distance to keep the pump/transmitter away from other RF devices? There is no need to separate the pump from other RF devices unless you are receiving interference. If you are receiving interference, reposition the devices until the interference stops. How often do I need to re-link the pump to MySentry? Unless you are experiencing RF interference that you cannot resolve, or there has been a system failure that has cleared the settings on the pump, you only need to link the pump to MySentry once. After initial linking, even if the power supply is unplugged, MySentry will automatically resynchronize upon power-up. If you do need to re-link, it may take up to seven minutes. 46 Frequently asked questions MySentry Monitor What if I cannot resolve RF interference issues? Re-link MySentry with the pump by performing the procedures in the Getting started chapter. What is the RF power used by our devices? Conducted RF:150KHz to 80MHz; Radiated radio frequency: 80 MHz to 2.5GHz • • • Paradigm 523/723 insulin pump: MySentry Monitor: Outpost: If I lose RF communication, what do I need to do to recover communication? If you lose RF communication, do the following: • • • Reorient or relocate the MySentry devices. Decrease the distance between the MySentry Monitor and MySentry Outpost to 100 feet or less. Decrease the distance between the MySentry Outpost and Paradigm 523/723 insulin pump to six feet or less. What if MySentry experiences a power failure? If a power failure occurs, the Monitor alarms for 15 seconds before turning itself off. Why are the buttons on the MySentry Monitor sometimes lighted and sometimes not lighted? To help you with navigate the system, only the active buttons are illuminated. What do the bars on the Outpost indicate? The bars are for cosmetic purposes only. The Outpost stays illuminated when there is a connection between it and the pump. Frequently asked questions 47 MySentry Monitor My Outpost is flashing very quickly. Does this indicate a problem? Yes. This indicates that the Outpost needs to be reset. To reset the Outpost, unplug it from the power outlet and then plug it back in. If unplugged, how long does it take for the pump and monitor to reconnect? It might take up to seven minutes. How long will it take for the pump and monitor to link during setup? It typically takes between five and 30 seconds for the pump to link to the Monitor. 48 Frequently asked questions MySentry Monitor End user software license agreement NOTICE TO USER: This is a legal agreement between you (an individual or entity, referred to hereinafter as “you”) and Medtronic MiniMed, Inc. (“MiniMed”) for any software embedded in the MySentry Monitor (“the Product”), including any related documentation, updates and upgrades (collectively referred to hereinafter as the “Software”). The Software is provided by MiniMed and its suppliers for use only as embedded in the Product. BEFORE USING THE PRODUCT OR THE SOFTWARE, YOU NEED TO REVIEW AND AGREE TO THE TERMS AND CONDITIONS OF THIS AGREEMENT. If you do not agree with the terms and conditions of this Agreement, return the Product, along with the packaging and related materials, to MiniMed or the place of purchase for a full refund. Grant of License. MiniMed grants you a limited, non-exclusive license to use the Software as embedded in the Product. Other Rights and Limitations. You agree not to reproduce, modify, separate the components of, adapt or translate or otherwise create derivative works from, the Software and further agree not to attempt to reverse engineer, decompile, disassemble or otherwise attempt to discover the source code of the Software. You may not rent, lease, distribute or lend the Software to third parties. You may, however, transfer all of your rights to use the Software to another person or legal entity to whom you provide the Product, provided that the recipient also agrees to the terms of this Agreement. Ownership. Title, ownership rights, and intellectual property rights in and to the Software shall remain with MiniMed or its suppliers. The Software is protected by United States Copyright Law and international copyright treaties, as well as other intellectual property laws and treaties. There is no transfer to you of any title to or ownership of the Software and this License shall not be construed as a sale of any rights in the Software. You agree not to remove or alter any copyright, trademark, End user software license agreement 49 MySentry Monitor registered mark and other proprietary notices on any copies of the Software. MiniMed and its suppliers reserve all rights not granted. Open Source. Notwithstanding anything else stated in this Agreement, to the extent, if any, all or any portion of the Software is provided under public license by third parties, such as that which is provided under any version of the GNU General Public License or GNU General Public License, both of which can be obtained through the GNU web site at http://www.gnu.org/copyleft/gpl.html (collectively, “Open Source”), such is licensed to you subject to the terms and conditions of the separate software license agreement for such Open Source. Use of the Open Source by you shall be governed entirely by the terms and conditions of such license. The source code for any Open Source can be obtained, for a nominal fee to cover the cost of shipping and media, by contacting MiniMed (see contact information below). The Software is also based in part on the work of the Qwt project (http://qwt.sf.net). Upgrades. If you acquire an upgrade, updated version, modified version, or additions to or for the Software from MiniMed, the upgrade, updated version, modified version, or addition, shall be included in the term Software and governed under this Agreement. Limited Warranty and Remedy. MiniMed warrants to you that the Software will perform substantially in accordance with the related explanatory written materials for a period of the ninety (90) days following the date of your original Product purchase. MiniMed does not warrant that the operation of the Software will be uninterrupted or error free or that the functions of the Software will meet your needs or requirements. MiniMed’s sole and exclusive liability and your exclusive remedy for breach of warranty shall be limited to either, at MiniMed’s option, the replacement of the Product or the Software therein, or to refund your money upon returning the Product. Any replacement will be warranted for the remainder of the original warranty period or thirty (30) days, whichever is longer. If the above remedy fails for any reason, MiniMed’s entire liability for a breach of warranty shall be limited to a refund of the price paid for the Product. This Limited Warranty is void if failure of the Software resulted from accident, abuse, or misapplication. You are solely responsible for decisions made and actions taken based on Software. THE STATED LIMITED WARRANTIES AND REMEDY ARE EXCLUSIVE AND IN LIEU OF ALL OTHERS. MINIMED DISCLAIMS ALL OTHER WARRANTIES, EITHER EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, ALL WARRANTIES OF NON-INFRINGEMENT, MERCHANTABILITY, AND FITNESS FOR A PARTICULAR PURPOSE. SOME STATES OR JURISDICTIONS, HOWEVER, DO NOT ALLOW EXCLUSIONS OR LIMITATIONS OF IMPLIED WARRANTIES, AND IN SUCH STATES, THE ABOVE LIMITATION MAY NOT APPLY TO YOU. 50 End user software license agreement MySentry Monitor Limitation of Liability. TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, IN NO EVENT WILL MINIMED OR ITS SUPPLIERS BE LIABLE FOR ANY DAMAGES, WHATSOEVER, WHETHER DIRECT, INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES, WHETHER ARISING UNDER CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY, BREACH OF WARRANTY, MISREPRESENTATION, OR OTHERWISE, INCLUDING WITHOUT LIMITATION, DAMAGES FOR LOSS OF BUSINESS PROFITS, BUSINESS INTERRUPTION, LOSS OF BUSINESS INFORMATION, OR OTHER PECUNIARY LOSS, ARISING OUT OF THE USE OF OR INABILITY TO USE THE SOFTWARE, OR ARISING OUT OF THIS AGREEMENT, EVEN IF MINIMED OR ITS REPRESENTATIVE HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. SOME STATES DO NOT ALLOW THE EXCLUSION OR LIMITATION OF DAMAGES IN CERTAIN TRANSACTIONS, AND IN SUCH STATES, THE ABOVE LIMITATIONS AND EXCLUSIONS MAY NOT APPLY. U.S. Government Acquisition of the Software. This Section applies to all acquisitions of the Software by or for the U.S. Government (“Government”), or by any prime contractor or subcontractor (at any tier) under any contract, grant, cooperative agreement, “other transaction” (“OT”), or other activity with the Government. By accepting delivery of the Software, the Government, any prime contractor, and any subcontractor agree that the Software qualifies as “commercial” computer software within the meaning of FAR Part 12, paragraph (b) of FAR Subpart 27.405, or DFARS Subpart 227.7202, as applicable, and that no other regulation, or FAR or DFARS data rights clause, applies to the delivery of this Software to the Government. Accordingly, the terms and conditions of this Agreement govern the Government’s (and the prime contractor and subcontractor’s) use and disclosure of the Software, and supersede any conflicting terms and conditions of the contract, grant, cooperative agreement, OT, or other activity pursuant to which the Software is delivered to the Government. If this Software fails to meet the Government’s needs, if this Agreement is inconsistent in any respect with Federal law, or if the above cited FAR and DFARS provisions do not govern, the Government agrees to return the Software, unused, to MiniMed. Export Restriction. You agree that the Product and the Software will not be shipped, transferred or exported into any country or used in any manner prohibited by the United States Export Administration Act or any other export laws, restrictions or regulations. 10 Governing Law and General Provisions. This Agreement shall be governed and construed under the laws in the State of California without regard to its conflicts of law rules. Any suit brought with respect to this Agreement may only be brought in Los Angeles, California and must be filed no later than one year after the date the Software is first acquired. This Agreement will not be governed by End user software license agreement 51 MySentry Monitor the United Nations Convention on Contracts for the International Sale of Goods, the application of which is expressly excluded. This Agreement is the entire agreement between the parties related to the Software and supersedes any purchase order, communication, advertisement, or representation concerning the Software. This Agreement shall be binding upon, and inure to the benefit of, the parties hereto and their respective successors, assigns and legal representatives. If any provision herein is found void or unenforceable, it will not affect the validity of the balance of the Agreement, which shall remain valid and enforceable according to its terms. This Agreement may only be modified in writing signed by an authorized representative of MiniMed. Without prejudice to any other rights MiniMed has, your warranty rights under Section 6 above, shall automatically terminate upon failure by you to comply with its terms, and MiniMed shall also have the right to terminate your license to use the Software and demand return of the Product for a refund based on the then present value of the Product. 11 Arbitration; Waiver of Right to Jury Trial and Participation in Class Actions. To the maximum extent permissible under applicable law: a. WAIVER OF JURY TRIAL. EACH OF US WAIVES OUR RESPECTIVE RIGHTS TO A TRIAL BY JURY OF ANY CONTROVERSY OR CLAIM (“CLAIM”) BETWEEN US ARISING OUT OF OR RELATING TO THE SOFTWARE OR THIS AGREEMENT (INCLUDING WITHOUT LIMITATION ANY COMMUNICATION OVER THE INTERNET INITIATED BY OR UNDER THE CONTROL OF THE SOFTWARE) OR ANY RELATED AGREEMENTS, INCLUDING WITHOUT LIMITATION ANY CLAIM BASED ON OR ARISING FROM AN ALLEGED TORT. ANY CLAIM SHALL INSTEAD BE DETERMINED BY BINDING ARBITRATION – EACH PARTY THUS WAIVES ITS RIGHT TO A JURY TRIAL. b. ARBITRATION. Arbitration shall be conducted in accordance with the Federal Arbitration Act (Title 9, U.S. Code), notwithstanding any choice of law provision in this Agreement, and under the rules of the American Arbitration Association (“AAA”). Either you or we may, by summary proceedings (e.g., a motion to stay further proceedings) bring an action in any court having jurisdiction for the sole purpose of compelling compliance with this arbitration provision. MiniMed may also initial any action in any court having jurisdiction for the additional purpose of obtaining temporary or preliminary injunctive relief that MiniMed reasonably believes necessary to protect its copyrights, and other proprietary and intellectual property rights, in the Software. The Proceeding shall be commenced at the request of the claiming party. A Claim shall be decided by one arbitrator who shall be a lawyer licensed to practice law in the state in which the arbitration 52 End user software license agreement MySentry Monitor Warranty Medtronic Diabetes warrants the Medtronic MySentry Monitor and MySentry Outpost against defects in materials and workmanship for a period of six months from the date of purchase. During the warranty period, Medtronic Diabetes will replace (with a new Monitor or Outpost) any defective Monitor or Outpost, subject to the conditions and exclusions stated herein. In the event that the Monitor or Outpost is replaced, the warranty period will not be extended. This warranty is valid only if the MySentry Monitor or MySentry Outpost is used in accordance with the manufacturer’s instructions. This warranty will not apply: • • • • • If damage results from changes or modifications made to the Monitor or Outpost by the user or third persons after the date of manufacture. If damage results from service or repairs performed by any person or entity other than the manufacturer. If damage results from a Force Majeure or other event beyond the control of the manufacturer. If damage results from negligence or improper use, including but not limited to: improper storage, submersion in water or physical abuse, such as dropping or otherwise. If changes or modifications not expressly approved by the party responsible for compliance are made. Such changes could void the user’s authority to operate the equipment. This warranty shall be personal to the original user. Any sale, rental or other transfer or use of the product covered by this warranty to or by a user other than the original user shall cause this warranty to immediately terminate. This warranty does not apply to any accessories. The remedies provided for in this warranty are the exclusive remedies available for any breach hereof. Neither Medtronic Diabetes nor its suppliers or distributors shall be liable for any incidental, consequential, or special damage of any nature or kind caused by or arising out of a defect in the product. All other warranties, expressed or implied, are excluded, including the warranties of merchantability and fitness for a particular purpose. Specifications 53 MySentry Monitor 54 End user software license agreement MySentry Monitor Index Numerics 24 Hour HelpLine 2 523/723 insulin pump 9 ACT button 14 Alarm screens 11 alarm volume, alarm silence, silence alarm, mute alarm 21 alarms glucose alarms 28 history of 29 monitor alarms 28 pump alarms 28 responding to 29 settings 28 stopping 29 assistance 2 backlight 20 battery installing 13–?? brightness 20 buttons 13 ACT 14 DOWN 13 communication status 17 confidential screen 27 contraindications 4 immunity 39 indications 4 insulin pump 9 display light 20 DOWN button 13, 14 electromagnetic 37, 39, 42 emissions 37 environment 42 glucose alarms 28 graphs 24 monitoring 23 sensor 9 viewing snapshot of 23 Glucose screens 11 glucose snapshot screen 23 graphs, glucose 24 Guidance and manufacturer’s declaration 37 help line 2 history of alarms 29 linking outpost 16 pump 15 monitor 9 buttons ACT 14 DOWN 13 monitor alarms 28 monitor screens 11 MySentry Monitor 9 MySentry Outpost 10 network loss 28 network status 17 NEXT button 14 nightlight 20 outpost 10 55 MySentry Monitor precautions 6 pump alarms 28 receiver 10 RF communications 42 screens Alarm 11 Glucose 11 status 12 Utilities 11 sensor 9 transmitter 10 UP button 14 Utilities screens 11 VIEW button 13 56 warnings 4
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